NCT07430605Not yet recruiting
WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor).
WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor)
Source: ClinicalTrials.gov · Last updated 24 Feb 2026
Brief summary (registry, in English)
This Phase II investigation evaluates the safety, usability, and clinical performance of the WearME-Pro patch system for remote monitoring of adults with COPD in a home-use environment. The protocol includes two components: (A) a \~1-month summative usability/human factors evaluation of the WearME-Pro patch, mobile app, and clinician dashboard; and (B) a 10-month longitudinal home-use study comparing WearME-Pro predicted lung function metrics (FEV1, FVC, FEV1/FVC) to an FDA-cleared handheld spirometer, with an adherence target of ≥85%. WearME-Pro outputs are investigational and are not used to direct clinical decisions during the study.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 82 (estimated)
- First submitted
- 10 Feb 2026
- Start date
- 1 May 2026
- Primary completion date
- 28 Apr 2028
- Lead sponsor
- LASARRUS Clinic and Research Center
- Diseases
- COPD
- NCT number
- NCT07430605
What you commit to
- Study type: Interventional
- Planned participants: 82
- From 1 May 2026 to the primary completion date, 28 Apr 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- COPD exacerbation within past 6 weeks requiring systemic corticosteroids and/or antibiotics, urgent/ED visit, or hospitalization.
Other illness
- Known allergy or severe skin sensitivity to medical adhesives, or dermatologic conditions at intended placement sites.
- Any condition that, in the investigator's opinion, may interfere with compliance or safety.
Other
- Inability or unwillingness to perform daily spirometry or to use the mobile app.
Who the study is looking for
- Age 21 years or older, either sex.
- Diagnosed with COPD per GOLD criteria (GOLD 2025): post-bronchodilator FEV1/FVC \< 0.70; stratified by post-bronchodilator FEV1% predicted (severity strata).
- On stable maintenance therapy for at least 2 months (no COPD medication class changes or dose escalations).
- Current, former, or never smoker (smoking history collected but not an eligibility requirement).
- Able to perform activities of daily living and complete study procedures (e.g., sit upright and perform spirometry maneuvers).
- Able and willing to provide informed consent.
- Not currently enrolled in another investigational device study that could confound outcomes (prior WearME-Basic Phase I participation permitted if completed and not concurrent).
- Owns a compatible smartphone/tablet or willing to use a loaner device.
- Willing to wear WearME-Pro patch and perform daily handheld spirometry throughout the study.
- Optional subset only: willing to wear Cardea SOLO ECG patch for up to 24-48 hours at baseline and end of study if selected.
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| LASARRUS Clinic and Research Center Inc. Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| TidalHealth Coordinator of this site? Confirm its status | Salisbury | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.